510(k) K254018
K254018 is an FDA 510(k) premarket notification submitted by Guilin Refine Medical Instrument Co., Ltd. for the device "Portable Dental X-ray Device (GT-1)". The FDA issued a decision of Substantially Equivalent on February 19, 2026. The device falls under product code EHD (Unit, X-Ray, Extraoral With Timer), a Class II device regulated under 21 CFR 872.1800. Guilin Refine Medical Instrument Co., Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 19, 2026
- Date Received
- December 15, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Unit, X-Ray, Extraoral With Timer
- Device Class
- Class II
- Regulation Number
- 872.1800
- Review Panel
- RA
- Submission Type